Roche’s Venclexta filed in the US for acute myeloid leukemia

The submission is seeking approval for use of the drug, in combination with a hypomethylating agent or in combination with low dose cytarabine (LDAC), for treatment of people with previously untreated AML who are ineligible for intensive chemotherapy.

The file contains data from two Phase Ib/II studies that evaluated Venclexta (venetoclax) in combination with azacitidine or decitabine (M14-358 study) or LDAC (M14-387 study) in this patient population.

Data from the M14-358 study showed that Venclexta in combination with azacitidine or decitabine resulted in a complete remission rate of 73 percent and, after more than a year of follow-up, median overall survival (OS) of 17.5 months.

Findings from the Phase Ib/II M14-387 study of Venclexta in combination with LDAC showed a complete remission rate of 62 percent and median overall survival of 11.4 months.

"Nearly 20,000 people will be diagnosed with AML in the US this year, and many of them are not eligible to receive standard intensive chemotherapy," said Sandra Horning, chief medical officer and head of Global Product Development at Roche.

"AML is an aggressive disease with the lowest survival rate of all leukaemias, and we look forward to working closely with the FDA to bring this potential option to patients with this very difficult-to-treat blood cancer as soon as possible."

Venclexta, which is being jointly developed by AbbVie and Genentech, is already on the market to treat people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior treatment.

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